CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 516 enrolled
Drug / intervention
Mavrilimumab 10 mg +4 morebiological
Likely dose
Mavrilimumab 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01050998
NCT01050998Phase 2Completed
CompareCT.gov

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects With Rheumatoid Arthritis

MedImmune LLC·interventional·Posted Jan 18, 2010·Updated Jun 25, 2018

In Brief

A Phase 2 clinical trial evaluating Mavrilimumab 10 mg, Mavrilimumab 30 mg, and 3 other interventions for Rheumatoid Arthritis. Completed, enrolled 516 participants across 55 sites in 11 countries.

Detailed Summary

The primary objectives of this study is to assess the safety, tolerability and efficacy of multiple doses of the mavrilimumab (CAM-3001) administered subcutaneously in subjects with moderately active Rheumatoid Arthritis (RA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBulgaria, Czechia, Estonia, Hungary, Japan, Latvia, Lithuania, Poland, Romania, Russia, Ukraine
CollaboratorsMedImmune Ltd

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 18, 2010
Enrollment StartJan 5, 2010
Primary CompletionJun 9, 2011
Study CompletionJul 27, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.5 years ago

Interventions

Mavrilimumab 10 mgbiological

Mavrilimumab (CAM-3001) 10 mg injection subcutaneously every other week for 12 weeks.

Mavrilimumab 30 mgbiological

Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks.

Mavrilimumab 50 mgbiological

Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks.

Mavrilimumab 100 mgbiological

Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks.

Placeboother

Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks.